N/A
N=82
Efficacy Study of FES Controlled by Electromyographic Signal for the Treatment of Upper Limb in Post-stroke Patients
Stroke
Bottom Line
View on ClinicalTrials.gov: NCT03019744 ↗Enrolled (actual)
82
Serious AEs
0.0%
Results posted
Sep 2018
Primary outcome: Primary: Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment — 6.6; 5.0 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MeCFES-assisted task-oriented upper limb rehabilitation (Device); Usual Care task-oriented upper limb rehabilitation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Fondazione Don Carlo Gnocchi Onlus
- Primary completion
- Nov 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change Score of ARAT Scale Between Two Time Points: Post-treatment vs Pre-treatment |
6.6; 5.0 | — |
| PRIMARY Change Score of FMA-UE Scale Between Two Time Points: Post-treatment vs Pre-treatment |
7.8; 4.5 | — |
| SECONDARY Change Score of IPPA Between Two Time Points: Post-treatment vs Pre-treatment |
-2.8; -3.2 | — |
| SECONDARY Change Score of DASH Between Two Time Points: Post-treatment vs Pre-treatment |
-4.8; -7.4 | — |
| SECONDARY Change Score of VAS for Perceived Pain Between Two Time Points: Post-treatment vs Pre-treatment |
0; 0 | — |
Summary
Goal of the present study is to evaluate the efficacy of Myoelectrically-controlled Functional Electrical Stimulation (MeCFES) for the rehabilitation of upper limb in post-stroke patients. MeCFES-assisted rehabilitation will be compared with usual care rehabilitation of upper limb. It is hypothesized that that applying MeCFES in rehabilitation to assist normal arm movements during rehabilitation of the upper limb in persons with stroke will improve the movement quality and success and thus induce recovery at the body functions level (impairment) and the activity level (disability) of the International Classification of Function (ICF) superior to that induced by usual care rehabilitation.
Eligibility Criteria
Inclusion Criteria
- Hemiplegia/hemiparesis due to a first ischemic or haemorrhagic stroke
- at least 1 month post-stroke
- willingness to participate the project
- minimum voluntary muscle activation of shoulder flexors (>1 Manual Muscle Test)
- passive Range of Motion (ROM) of the shoulder and elbow of more than 90°
Exclusion Criteria
- epilepsy
- severe spasticity at upper limb (>= 3 Ashworth scale)
- implanted electronic device
- respiratory insufficiency
- pregnancy
- peripheral neuropathies
- cutaneous ulcers at the stimulation zone
- other use of FES on the upper limb
Data sourced from ClinicalTrials.gov (NCT03019744). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.